Even if you unblind the results, you will have to face the FDA indirectly.
Pursue EUA with FDA: I'm sorry we are being more stringent now that prior approved treatments are not really effective.
Ignore the FDA and shop around: Did you pursue an EUA with the FDA? Why not? Why are you circumventing the recommendations of the DSMC?
I realize that taking the penalty won't really hurt the stat sig, and I'm sure the DSMC does as well. So there must be another reason for suggesting the 3/4 interim. What if it better demonstrates the ineffectiveness of the other treatments in the placebo group?
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